Prosthesis, Hip, Femoral Component, Cemented, Metal

Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

Inconsistent size terminology and color coding used on labeling

Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

Inconsistent size terminology and color coding used on labeling

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Moore & Thompson Hip Stems:

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length.

Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lot

MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.